Efficacy and tolerability of a nutraceutical combination of red yeast rice, guggulipid, and chromium picolinate evaluated in a randomized, placebo-controlled, double-blind study

Complement Ther Med. 2020 Jan:48:102282. doi: 10.1016/j.ctim.2019.102282. Epub 2019 Dec 16.

Abstract

Hypercholesterolemia is the major risk factor in the development of coronary heart disease. Coronary heart disease is a leading cause of morbidity and mortality in many countries worldwide. An increasing attention is now paid to nutraceuticals development for prevention and cure of dyslipidemia, especially for patients who do not wish to use chemical statins. The cholesterol lowering effect and the tolerability of NutraforChol®, a nutraceutical product containing red yeast rice extract, guggulipid extract and chromium picolinate, was evaluated on subjects who had total cholesterol level 200-239 mg/dL and LDL cholesterol level 100-159 mg/dL. In this study, a randomized, placebo-controlled, double-blind study which consisted of 4 weeks run-in period and 8 weeks treatment period was performed. Based on the study results, NutraforChol® effectively decreased total cholesterol (-15.9 %) and LDL level (-19.9 %) after two weeks consumption. The total cholesterol and LDL reduction were maintained during 8 weeks study period. At study termination (week 8), there was a significant difference between total cholesterol level of NutraforChol® treated group (173.5 ± 21.7 mg/dL) and placebo-treated group (204.5 ± 22.8 mg/dL) (p < 0.05). In addition, there was a significant difference between LDL level at week 8 in NutraforChol® group (115.5 ± 22.2 mg/dL) and placebo-treated group (145.1 ± 23.7 mg/dL) (p < 0.05). The tolerability of NutraforChol® was also evaluated. There were no significant changes (p > 0.05) on renal and liver function parameters between baseline and study termination. Thus, NutraforChol® may be considered as a complementary or alternative safe nutraceuticals for the treatment of mild dyslipidemic subjects.

Keywords: Guggulipid; LDL cholesterol; Randomized clinical trial; Red yeast rice; Total cholesterol.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Biological Products / therapeutic use*
  • Commiphora
  • Diet, Healthy
  • Dietary Supplements*
  • Double-Blind Method
  • Exercise
  • Female
  • Humans
  • Hypercholesterolemia / prevention & control*
  • Male
  • Middle Aged
  • Picolinic Acids / therapeutic use*
  • Plant Extracts / therapeutic use*
  • Plant Gums / therapeutic use*
  • Young Adult

Substances

  • Biological Products
  • Picolinic Acids
  • Plant Extracts
  • Plant Gums
  • red yeast rice
  • guggulu extract
  • picolinic acid